[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554313":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":44,"studyPopulation":36,"armGroups":45,"interventions":63,"overallOfficials":80,"centralContacts":84,"locations":93,"responsibleParty":182,"collaborators":184,"id":188,"slug":189,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":190,"sex":196,"minAge":197,"maxAge":198,"enrollmentInfo":199,"targetDuration":36,"studyType":202,"phases":203,"briefSummary":205,"conditions":206,"keywords":36,"overallStatus":96,"whyStopped":36,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Among treatment-naïve participants with HIV-1 who are taking rifampin-based regimens for TB, determine the proportion with HIV-1 virologic suppression (via FDA snapshot algorithm) at 28 weeks of HIV treatment, by arm","To Compare the proportion of participants with HIV-1 virologic suppression at 28 weeks of HIV treatment by arm.","28 weeks",[14,18,21,25,29,32],{"measure":15,"description":16,"timeFrame":17},"1.3.1 Number of patients with HIV-1 virologic suppression (via FDA snapshot algorithm) at 48 weeks, in each arm","To compare the proportion in each arm above DTG protein adjusted 90% inhibitory concentration (IC90) (64 ng\u002FmL) at each PK sampling.","48 weeks",{"measure":19,"description":20,"timeFrame":17},"1.3.2 Number of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG\u002F3TC arms (Arm 1 + Arm 2)","To compare the proportion of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG\u002F3TC arms (Arm 1 + Arm 2)",{"measure":22,"description":23,"timeFrame":24},"1.3.3 Change from baseline in CD4 over 28 weeks and 48 weeks of HIV treatment, by arm","To compare the changes from baseline over 28 weeks and 48 weeks of HIV treatment by the arm.","28 weeks, 48 weeks",{"measure":26,"description":27,"timeFrame":28},"1.3.4 Proportion of participants with DTG Cmin above target DTG trough of 158 ng\u002FmL","1-To estimate the pharmacokinetics (PK) of DTG when given twice daily as a 50 mg\u002F 300 mg DTG\u002F3TC FDC with rifampicin (RIF)-containing TB treatment, X DTG 50 mg\u002F 3TC 300 mg FDC given once daily without RIF among the same participants after completing TB treatment.","2years",{"measure":30,"description":31,"timeFrame":28},"1.3.4 Concentration of the PK of DTG","Concentration of DTG when given twice daily as a 50 mg\u002F 300 mg DTG\u002F3TC FDC with RIF-containing TB treatment, X DTG 50 mg\u002F 3TC 300 mg FDC given once daily without RIF among the same participants after completing TB treatment.",{"measure":33,"description":34,"timeFrame":35},"1.3.5 Compare Grade 3 or 4 adverse events, by arm","To compare the Grade 3 \\& 4 adverse events by arm","2 years",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":36,"timePerspective":36,"maskingInfo":42},"RANDOMIZED","PARALLEL","Arm 1(n=50): DTG 50mg\u002F3TC 300 mg FDC tablet (Dovato®) twice daily during TB therapy and for 2 weeks after, then Dolutegravir (DTG) 50mg \u002F lamivudine (3TC) 300 mg fixed dose combination (FDC) tablet (Dovato®) once daily to week 52\n\nArm 2(n=50): DTG 50mg\u002F300mg FDC tablet plus DTG 50mg at night during TB treatment and for 2 weeks after, then DTG 50 mg\u002F 3TC 300 mg FDC tablet (Dovato®) once daily to week 52\n\nArm 3(n=50): Local Standard of Care 3-drug ART (DTG 50mg + TDF\u002F3TC) plus DTG 50 mg at night during TB treatment and for 2 weeks after, then Dolutegravir (DTG) 50 mg + Tenofovir disoproxil fumarate (TDF)\u002F lamivudine (3TC) FDC tablet once daily to week 52","TREATMENT",{"masking":43,"maskingDescription":36,"whoMasked":36},"NONE","Tuberculosis (TB) is the most common cause of death in people with HIV worldwide. Among patients with HIV, the incidence of TB per year is about 5-10%. The two diseases are now always treated concurrently in co-infected individuals, as there is a survival benefit for starting antiretroviral therapy (ART) soon after TB treatment initiation. Current Brazilian guidelines suggest that for patients with a cluster of differentiation 4 (CD4) \\\u003C 50, ART should be started within 2 weeks of starting TB treatment; for patients with a CD4\\>50, ART should be started within 2 months of starting TB treatment. World Health Organization guidelines suggest ART initiation within 2 weeks of TB diagnosis regardless of CD4 count (provided there are no signs of TB meningitis), but most programs defer ART until 6-8 weeks in patients with CD4 \\>50 to reduce the risk of immune reconstitution inflammatory syndrome (IRIS).\n\nThe option of dual therapy for HIV (i.e., complete regimens to treat HIV composed of only 2 drugs) is of increasing interest and can lower costs for patients, payors, and programs while lowering cumulative lifetime exposure to ART (with potential resultant lessened burden of cumulative toxicities) and maintaining high antiviral efficacy. Based on the GEMINI, TANGO, and SALSA clinical trials, a regimen of 50 milligram (mg) DTG combined with 300mg lamivudine (3TC) has been shown to be a highly effective stand-alone option for the treatment of HIV-1 in ART treatment-naïve or virologically suppressed individuals through 48 weeks (SALSA) and 144 weeks (GEMINI and TANGO).",[46,52,57],{"label":47,"type":48,"description":49,"interventionNames":50},"Arm 1: DTG 50 mg\u002F 3TC 300mg (Dovato®) twice daily (BID)","EXPERIMENTAL","Arm 1: DTG 50mg\u002F3TC 300 mg fixed-dose-combination (FDC) tablet (Dovato®) twice daily during TB therapy and for 2 weeks after, then DTG 50mg\u002F3TC 300 mg FDC tablet (Dovato®) once daily to week 52",[51],"Drug: Dolutegravir\u002FLamivudine 50 MG-300mg Oral Tablet [DOVATO]",{"label":53,"type":48,"description":54,"interventionNames":55},"Arm 2: DTG 50 mg\u002F 3TC 300mg (Dovato®) once daily (QD) in the morning with DTG 50 mg in the evening","Arm 2: DTG 50mg\u002F300mg FDC tablet plus DTG 50mg at night during TB treatment and for 2 weeks after, then DTG 50 mg\u002F 3TC 300 mg FDC tablet (Dovato®) once daily to week 52",[56,51],"Drug: Dolutegravir 50mg Tab",{"label":58,"type":59,"description":60,"interventionNames":61},"Arm 3: Standard of Care 3-drug ART (DTG+ TDF\u002F3TC) plus DTG 50mg in the evening.","ACTIVE_COMPARATOR","Arm 3: Local Standard of Care 3-drug ART (DTG 50mg + TDF\u002F3TC) plus DTG 50 mg at night during TB treatment and for 2 weeks after, then DTG 50 mg + TDF\u002F3TC FDC tablet once daily to week 52",[62],"Drug: Dolutegravir plus Tenofovir disoproxil fumarate (TDF)\u002F lamivudine (3TC)",[64,72,76],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"DRUG","Dolutegravir 50mg Tab","Participants will receive Dolutegravir 50mg",[53],[70,71],"TIVICAY 50 mg","TIVICAY PD",{"type":65,"name":73,"description":74,"armGroupLabels":75,"otherNames":36},"Dolutegravir\u002FLamivudine 50 MG-300mg Oral Tablet [DOVATO]","Participants will receive Dolutegravir\u002FLamivudine 50 MG-300 MG Oral Tablet \\[DOVATO\\]",[47,53],{"type":65,"name":77,"description":78,"armGroupLabels":79,"otherNames":36},"Dolutegravir plus Tenofovir disoproxil fumarate (TDF)\u002F lamivudine (3TC)","Participants will receive Dolutegravir plus Tenofovir disoproxil fumarate (TDF)\u002F lamivudine (3TC)",[58],[81],{"name":82,"affiliation":5,"role":83},"Ethel M Weld, MD","PRINCIPAL_INVESTIGATOR",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":36,"email":89},"Beatriz M Kohler, RN","CONTACT","410 614 3812","bkohler@jhmi.edu",{"name":91,"role":87,"phone":36,"phoneExt":36,"email":92},"Kate Boehner, RN","kboehne1@jh.edu",[94,118,134,152,164],{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Instituto Tropical de Doenças Infecciosas Manaus","RECRUITING","Manaus","Amazonas","69040-000","Brazil","BR",{"type":103,"coordinates":104},"Point",[105,106],-60.025,-3.10194,{"lat":106,"lon":105},[109,113,116],{"name":110,"role":87,"phone":111,"phoneExt":36,"email":112},"Marcus Lacerda, MD, PhD","+55 92 99114-7633","marcuslacerda.br@gmail.com",{"name":114,"role":87,"phone":115,"phoneExt":36,"email":36},"Marcelo Cordeiro,,MD, PhD","+55 92 98533-3533",{"name":117,"role":83,"phone":36,"phoneExt":36,"email":36},"Marcus Lacerda, MD,PhD",{"facility":119,"status":96,"city":120,"state":121,"zip":122,"country":100,"countryCode":101,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Universidade Federal da Bahia","Salvador","Estado de Bahia","40110-160",{"type":103,"coordinates":124},[125,126],-38.49096,-12.97563,{"lat":126,"lon":125},[129,133],{"name":130,"role":87,"phone":131,"phoneExt":36,"email":132},"Carlos Brites, MD, PhD","+55 71 992329552","crbrites@gmail.com",{"name":130,"role":83,"phone":36,"phoneExt":36,"email":36},{"facility":135,"status":96,"city":136,"state":136,"zip":137,"country":100,"countryCode":101,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"FIOCruz","Rio de Janeiro","21040-360",{"type":103,"coordinates":139},[140,141],-43.18223,-22.90642,{"lat":141,"lon":140},[144,148,151],{"name":145,"role":87,"phone":146,"phoneExt":36,"email":147},"Valeria Rolla, MD","+55 21 99490-4251","valeria.rolla@ini.fiocruz.br",{"name":149,"role":87,"phone":36,"phoneExt":36,"email":150},"Aline Benjamin, PhD","alinebenjaminipec@gmail.com",{"name":145,"role":83,"phone":36,"phoneExt":36,"email":36},{"facility":153,"status":96,"city":136,"state":136,"zip":154,"country":100,"countryCode":101,"cosmosGeoPoint":155,"geoPoint":157,"contacts":158},"Hospital Geral de Nova Iguaçu","26210-190",{"type":103,"coordinates":156},[140,141],{"lat":141,"lon":140},[159,163],{"name":160,"role":87,"phone":161,"phoneExt":36,"email":162},"Aline Ramalho, MD","+55 22 996107788","alineramalhopesquisa@gmail.com",{"name":160,"role":83,"phone":36,"phoneExt":36,"email":36},{"facility":165,"status":96,"city":166,"state":167,"zip":168,"country":100,"countryCode":101,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"CePClin - Center for Studies and Research in Infectious Diseases Ltda","Natal","Rio Grande do Norte","59.025-050",{"type":103,"coordinates":170},[171,172],-35.20944,-5.795,{"lat":172,"lon":171},[175,179],{"name":176,"role":87,"phone":177,"phoneExt":36,"email":178},"Mônica Bay B Bay, MD","+55 84 994141921","monibay@gmail.com",{"name":180,"role":87,"phone":36,"phoneExt":36,"email":181},"Sibele F Araújo","sibelearaujo@cpclinrn.com.br",{"type":183,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[185],{"name":186,"class":187},"ViiV Healthcare","INDUSTRY","100554313","phase-3-dolutegravirlamivudine-dual-therapy-for-art-nave-people-with-hiv-and-tb-receiving-rifampin-based-tb-treatment-100554313",false,"NCT06497465","Dolutegravir\u002FLamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment","Dolutegravir Plus Lamivudine (DTG\u002F3TC) Dual Therapy Versus Dolutegravir With TDF-lamivudine (DTG + TDF\u002F3TC) Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment","DOVETAIL","Inclusion Criteria:\n\n* Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and\u002For E\u002FCIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load. Two or more HIV-1 RNA viral loads of \\>1,000 copies\u002FmL are also acceptable as documentation of HIV-1 infection.\n* CD4+ cell count ≥50 cells\u002Fmm3 obtained within 30 days prior to study entry\n* HIV-1 viral load ≥1000 copies\u002FmL\n* ART-naïve.\n* Documentation of pulmonary TB identified by:\n\nAt least one sputum specimen positive for M. tuberculosis by molecular TB assay (Xpert) or line probe assay \\[LPA\\]), and RIF resistance not detected.\n\nOR Culture positive for MTB OR Positive Urinary Lipoarabinomannan (LAM) testing OR Clinical diagnosis of tuberculosis with no microbiological confirmation\n\nExclusion Criteria:\n\n* Pregnant, or plans to become pregnant.","ALL","15 Years","99 Years",{"count":200,"type":201},150,"ESTIMATED","INTERVENTIONAL",[204],"PHASE3","This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG\u002F3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard of care (SOC) twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate \u002Flamivudine (TDF\u002F3TC), among antiretroviral therapy (ART)-nave individuals with HIV-1 receiving rifampin-based TB therapy",[207,208],"Tuberculosis","HIV","2026-09-09",{"date":211,"type":212},"2026-09-11","ACTUAL",{"date":214,"type":212},"2025-09-18",{"date":216,"type":201},"2029-01-31",{"name":5,"class":6},5]